3 - PHARMACEUTICAL MANUFACTURING - CURRENT GOOD MANUFACTURING PRACTICES
Current Good Manufacturing Practices
these are guidelines to make sure that the
quality of the product is always followed. They
are guidelines to monitor and maintain the
manufacturing facilities and processes.
Iba-iba ang guidelines sa iba’t-ibang products.
Our main concern kase is to produce quality
and effective medicines.
A.O. 43 s. 1999
CURRENT GOOD MANUFACTURING
PRACTICE GUIDELINES FOR DRUGS
SEPTEMBER 29, 1999
PART 1 GENERAL PROVISIONS
⚫ Section 1: Authority
⚫ Section 2: Statement of Policies
⚫ Section 3: Statement of Objectives
⚫ Section 4: Definition of Terms -- Activity
PART 2 BASIC GMP GUIDELINES
⚫ 12 Sections
PART 3 STERILE PRODUCTS
GUIDE TO GOOD MANUFACTURING
PRACTICE FOR MEDICINAL PRODUCTS
Pharmaceutical Inspection Co-operation
Scheme (PIC/S)
⚫ CHAPTER 1 – QUALITY
MANAGEMENT
⚫ CHAPTER 2 – PERSONNEL
⚫ CHAPTER 3 – PREMISES AND
EQUIPMENT
⚫ CHAPTER 4 – DOCUMENTATION
⚫ CHAPTER 5 – PRODUCTION
⚫ CHAPTER 6 – QUALITY CONTROL
⚫ CHAPTER 7 – CONTRACT
MANUFACTURE AND ANALYSIS
⚫ CHAPTER 8 – COMPLAINT AND
PRODUCT RECALL
⚫ CHAPTER 9 – SELF-INSPECTION
the last three are post marketing
studies
QUALITTY MANAGEMENT (SECTION I)
PRINCIPLE
Quality Objective:
MAH / MA (Marketing Authorization Holder/
Marketing Authorization) must manufacture
medicinal products so as to ensure that they
are fit for their intended use, comply with the
requirements of the MA and do not place
patient at risk due to inadequate safety,
quality and efficacy. Safety, Quality and
Efficacy are our main goals as pharmacists.
Especially sa quality control, this is our main
object: to provide safe, quality, and effective
medicine.
Attainment of Quality Objective
⚫ Responsibility of the senior
management
⚫ Requires participation and commitment
by staff, company’s suppliers and by
the distributors.
Of course, like what we mentioned last
time, in the manufacturing firm, it is
very important to have teamwork. Like
in other areas of the pharmaceutical
industry, or sa profession naten, we all
need to communicate. Good dapat
communication ng different
departments kase even one mistake
can be a major problem.
Di daw pwede si ma’am sa ganitong
practice kase di pwedeng maging
makakalimutin dito. Bawal din
magkamali ng measurement. Dapat
you have a good memory and good
state of mind if you are working sa
manufacturing firm. The commitment of
the staff is important.
⚫ There must be comprehensively
designed and correctly implemented
system of QA incorporating GMP, QC
and Quality Risk Management. ~
Inter-related ang tatlong to. Bawal
sara-sariling galaw. They should have
good teamwork.
QUALITY ASSURANCE
Responsibilities--
⚫ Covers all matters influencing the
quality of a product.
⚫ Ensures that medicinal products are of
the quality required for their intended
use.
⚫ Incorporates GMP
If you heard about the GMP sa ibang
companies, it is strictly followed. May
internal and external inspections. Tulad
ng sa university. Ibig sabihin, may
designated inspectors in the company,
tapos meron ding magchcheck galing
sa labas from time to time. Just in case.
Halimbawa may isang paper na di
nasubmit ng maayos, or may
contamination doon sa isang
equipment, everything else will be
3 - PHARMACEUTICAL MANUFACTURING - CURRENT GOOD MANUFACTURING PRACTICES
affected. Pwedeng ipasara temporarily
yung establishment until masettle na
yung GMP.
Syempre kasali sa GMP yung
environment daw. Like dapat malinis.
Cleanliness in every aspect is very
important especially for medicines.
Baka ikabankrupt pa ng company pag
may nakitang mali. It can also lead to
public discrimination.
Example daw winithdraw daw yung
milk. Sa box daw dati kase for 0-6
months, naging 6-12 months. Delikado
sa baby yon, baka madehydrate sya,
baka may contamination of bacteria, or
baka magka LBM pa yung baby.
The system of QA should ensure that:
 medicinal product are designed and
developed based on GMP;
 production & control operations are clearly
specified and GMP practice adopted;
Llahat from operations pati sa managerial
responsibilities nasa GMP din.
 managerial responsibilities are clearly
specified;
 arrangements are made for the
manufacture, supply and use of the correct
starting and packaging materials;
 all necessary controls on intermediate
products, and any other in-process controls
and validations are carried out;
 the finished product is correctly processed
and checked;
 medicinal products are not sold or supplied
before an authorized person has certified
that each production batch has been
produced and controlled based on the
requirements of the marketing
authorization and any other regulations;
 satisfactory arrangements exist to ensure
that the medicinal products are stored,
distributed, and subsequently handled so
that quality is maintained throughout their
shelf-life;
So even though it will be distributed already,
the QA should endure if the quality is still
maintained. Example, yung sa vaccines,
merong temperature na need. The QA will
make sure nga daw na mamaintaing daw
throughout their shelf-life.
 there is a procedure for self-inspection
and/or quality audit, which regularly
appraises the effectiveness and
applicability of the quality assurance
system.
Again, just like in all companies, they have
self-inspection. May internal audit and
external audit. Basta it’s a good company
may ganito sya. Sa small companies daw
wala. For drug stores, usually may
designated na mga tao. Sa community daw
may designated books Boehringer
company daw hawak nya. Yung other
pharmacy assistant hawak nya book 2.
Book 2 daw is GSK (Glaxo Smithkline).
Kanya-kanyang book, they will all inspect
yung products sa book nila to make sure na
hindi expired.
QA will determine its effectiveness and
its applicability.
Wala talagang sense si ma’am masyado
sorry.
GOOD MANUFACTURING PRACTICE
⚫ Part of QA
⚫ Ensures that medicinal products are
consistently produced and controlled to
the quality standards appropriate for
their intended use and as required by
the MA or product specification.
⚫ Concerned with both production and
QC
Remember that QC and QA work hand
in hand because they are in the same
department- Total Quality Control.
The basic requirements of GMP are that:
 all manufacturing processes are clearly
defined, systematically reviewed and
capable of consistently manufacturing
products of the required quality and
complying with their specifications;
 critical steps of manufacturing processes
and significant changes to the process are
validated;
Remember, in the manufacturing firm, they
have a system. They follow the
manufacuring guidelines. They follow these
guidelined for the efficacy, safety, and
quality of products.
Yung difference daw ng CGMP sa GMP
yung lang C, of course it is current. This
means it is the most updated GMP.
 all necessary facilities for GMP are
provided;
3 - PHARMACEUTICAL MANUFACTURING - CURRENT GOOD MANUFACTURING PRACTICES
 instructions and procedures are written in
an instructional form;
 operators are trained to carry out
procedures correctly;
it is also indicated if the operator of the
equipment has proper training. Hindi yung
basta bastang tinuruan lang ng kasama.
Ofcourse yung iba employees pwedeng
matrain ng co-operators. But then, thy are
still required to have certifications. Minsan
may seminar pa or practice training. This is
to ensure na they are fit to operate certain
equipment.
 records are made during manufacture and
that the quantity and quality of the product
was as expected, any deviations are fully
recorded and investigated. In clear and
unambiguous language, manually or by
recording instruments.
Again, the QA and QC make sure na
walang deviation sa quantity kahit
konting-konti lang Kase it might become
significant. Pag sa whole batch siguro
tapos point something lang, okay lang.
Pero may guidelines parin daw sa pag di
nag comply, it will be recorded, and it will
be investigated by internal and external
audit.
 records of manufacture including
distribution – enable history of batch to be
traced are retained in a comprehensible
and accessible form;
Kaya mas maganda kung organized ka dito
tsaka hindi makakalimutin. You should
have good memory and organization skills.
If wala kase, you’re not fit for this. But of
course, pwede naman pag-aralan or ayusin
yung ganoong attitude. But ofcourse daw
very important at very crucial kase dito.
(Legit verbatim yan ayaw ko na din).
Before mag release ng product it has to
be checked. Sa post-marketing, nag
chcheck from time to time, randomly. If may
problem magttrace back. So kailangan,
yung pagffile mo should be in a
comprehensible and accessible form. Para
pag may problema mare-recall nang
madali.
 the distribution (wholesaling) of the
products minimizes any risk to their quality;
 a system is available to recall any batch of
product, from sale or supply;
 complaints about marketed products are
examined, causes of quality defects
investigated and appropriate measures
taken and to prevent re-occurrence.
It might cost the company a lot of money.
This can also lead to bankruptcy.
Dapat mag-set ng preventive measures
para di na maulit, kase iimbestigahan yung
QA kung ano yung action nila towards the
problem, at kung ano ang dahilan bat
nangyari yon.
QUALITY CONTROL
Focused on sampling and testing
⚫ Part of GMP concerned with sampling,
specifications and testing, and with the
organization, documentation and
release of procedures.
⚫ Ensures that materials are not released
for use and products released for sale
or supply until their quality had been
judged to be satisfactory. (MAIN
RESPONSIBILITY DAW TO)
If substandard ang product or if may
discrepancy, silang lahat damay.
Wag daw magsisihan.
The basic requirements of QC are that:
 adequate facilities, trained personnel and
approved procedures are available;
 samples of starting and packaging
materials, intermediate, bulk and finished
products are taken by personnel and by
methods approved by QC;
 test methods are validated;
 records are made which demonstrate that
all required sampling, inspecting and
testing procedures were carried out. Any
deviations are recorded and investigated;
Kaya very important daw to be organized.
Sobrand strict sa QC.
 the finished products contain AI complying
with the qualitative and quantitative
composition of the marketing authorization,
are of the purity required and are enclosed
with their proper containers and correctly
labeled;
Example yung Ranitidine HCl, Brand name:
Peptica, 150mg. Recalled nung 2020. This
was a medication used for peptic ulcers.
Voluntarily recalled sya kase natuklasan na
it contains Nitrosodimethylamine, human
carcinogen. From India daw to. Rinecall
due to quality and safety concerns.
 records are made of the results of
inspection and that testing of materials,
3 - PHARMACEUTICAL MANUFACTURING - CURRENT GOOD MANUFACTURING PRACTICES
intermediate, bulk and finished products is
formally assessed against specification;
 no batch of product is released for sale or
supply prior to certification by an authorized
person;
Again, without certification or authorization,
a product can’r be released to the market.
 sufficient reference samples of starting
materials and products are retained to
permit future examination of the product.
Example gumawa ka ng tablet, dapat
meron kang control. Negative at Positive
control. Kunware may daga na walang
gagawin sa kanya. Para mainspect mo
yung future problems.
Example, minsan yung raw materials or
starting materials, malalaman mo na
pumapanget quality kase masyado nang
matagal daw na nakastore. Kase may
tinest mo yung quality nila habang nasa
storage habang tumatagal.
PRODUCT QUALITY REVIEW
⚫ Regular periodic or rolling quality
reviews of all licensed medicinal
products should be conducted.
Objective:
 Should be conducted and documented
annually, taking into account previous
reviews.
Para malaman yung nangyari sa product at
para may documentation.
Should include at least:
 A review of starting materials including
packaging materials.
Documentation is important daw.
 A review of critical in-process controls and
finished product results.
Documentation is importatn ulit.
 A review of all batches that failed to meet
established specification(s) and their
investigation.
 A review of all significant deviations or
non-conformances, the effectiveness of
resultant corrective and preventative
actions taken.
Kailangan daw kase organized lahat. So
ayon sa documentation, kasali yung sa
starting materials, method, personnel, all
batches released, all batches na nareject,
all conformance, all standard deviations,
nandoon lahat.
Pag may time na di nakapag conform,
maglagay ng preventive measures para di
na maulit yun, para maayos na next time.
Example ulit, nung gumawa daw silang
suppositories, nakailang try daw sila bago
naging successful. Nag modify sila, tapos
yung modifications dinocument daw sa lab
manual ganon para sa susunod na
gagawin okay na.
 A review of all changes carried out to the
processes or analytical
methods.
Verifying consistency of the existing
process, appropriateness of current
specifications for both starting materials
and finished products
Kung ano man yung kinailangan iadjust,
isulat yun sa documentation.
 A review of MA variations
submitted/granted/refused, including those
for third country (export only) dossiers.
All documentaries are reviewed by the
product quality review.
 A review of the results of the stability
monitoring programme and any adverse
trends.
 A review of all quality-related returns,
complaints and recalls and the
investigations performed at the time.
 A review of adequacy of any other previous
product process or
equipment corrective actions.
 For new MA and variations to MA, a review
of post-marketing commitments.
 The qualification status of relevant
equipment and utilities.
 A review of any contractual arrangements
to ensure that they are up to date.
Lahat ng departments dapat chinecheck to.
QUALITY RISK MANAGEMENT
Dito napupunta products after QC and QA.
QC and QA daw kase nag ffocus on
manufacturers and products mismo. Ito more
on the protection of the patient.
⚫ Systematic process for the assessment,
control, communication and review of
risks to the quality of the medicinal
product.
⚫ It can be applied both proactively and
retrospectively.
Kung ano man ang nag-eexist in the
present, atsaka doon sa dati.
Should ensure that:
 the evaluation of the risk to quality is based
on scientific knowledge, experience with
3 - PHARMACEUTICAL MANUFACTURING - CURRENT GOOD MANUFACTURING PRACTICES
the process and ultimately links to the
protection of the patient;
 the level of effort, formality and
documentation of the quality risk
management process is commensurate
with the level of risk.
CONTRACT MANUFACTURE AND
ANALYSIS (SECTION VII)
CMO (Contract Manufacturing Organization)
/CDMO (Contract Development and
Manufacturing Organization)
⚫ a company that serves other companies in
the pharmaceutical industry on a contract
basis to provide comprehensive services
from drug development through drug
manufacturing.
⚫ Allows major pharmaceutical companies to
outsource those aspects of the business
which can help with scalability or can allow
the major company to focus on drug
discovery and drug marketing instead.
PRINCIPLE
✓ Contract manufacture and analysis must be
correctly defined, agreed and controlled in
order to avoid misunderstandings which
could result in a product or work of
unsatisfactory quality.
Written contract is between the giver and
the acceptor.
✓ There must be a written contract between
the Contract Giver and the Contract
Acceptor which clearly establishes the
duties of each party.
There should be a written contract covering
the manufacture and/or analysis
arranged under contract and any technical
arrangements made in connection
with it.
All arrangements for contract manufacture
and analysis including any proposed
changes in technical or other arrangements
should be in accordance with the
marketing authorization for the product
concerned.
✓ The contract must clearly state the way in
which the authorized person releasing each
batch of product for sale exercises his full
responsibility.
I. THE CONTRACT GIVER
Responsible for assessing the competence of
the Contract Acceptor.
⚫ To carry out successfully the work
required
⚫ Ensuring by means of the contract that
the principles and Guidelines of GMP
are followed
⚫ Provide the Contract Acceptor with all
the information necessary to carry out
the contracted operations correctly (MA,
other legal requirements)
⚫ Ensure that the Contract Acceptor is
fully aware of any problems associated
with the product or the work. Which
might pose a hazard to his premises,
equipment, personnel, other materials
or other products.
⚫ Ensure that all processed products and
materials delivered to him by the
Contract Acceptor comply with their
specifications or that the products have
been released by an authorized
person.
II. THE CONTRACT ACCEPTOR
Example: Contract giver is yung supplier tapos
Contract acceptor naman yung company owner.
Pwede ding Contract giver yung company
owner, Contract acceptor naman yung
Distributor.
⚫ Must have adequate premises and
equipment, knowledge and experience,
and competent personnel to carry out
satisfactorily the work ordered by the
Contract Giver.
⚫ Contract manufacture may be
undertaken only by a manufacturer
who is the holder of a MA.
⚫ Ensure that all products or materials
delivered to him are suitable for their
intended purpose.
⚫ Should not pass to a third party any of
the work entrusted to him under the
contract without the Contract Giver's
prior evaluation and approval of the
arrangements.
Kadalasan, a contract is just between
the giver and the acceptor. Kaya
double check lagi, wag magsisihan.
⚫ Arrangements made between the
Contract Acceptor and any third party
should ensure that the manufacturing
and analytical information is made
available in the same way as between
3 - PHARMACEUTICAL MANUFACTURING - CURRENT GOOD MANUFACTURING PRACTICES
the original Contract Giver and
Contract Acceptor.
In the event na there’s another party
involved, like example daw Big
Company, yung sister company, and
then supplier. Dapat aware sa
napag-usapan yung sister company,
like kung paano yung arrangement.
⚫ Should refrain from any activity which
may adversely affect the quality of the
product manufactured and/or analyzed
for the Contract Giver.
Acceptor should make sure that the
quality of products or raw materials
given to the company will be taken care
of. Hindi pwedeng manisi.
It’s important to have a document para
may habol ka, may proof ka. Term ni
Ma’am is kailangan nakapaper, in black
and white.
USUALLY sa storage nagkakachange
or nagkakaproblem. Kaya dapat you
double check, wag kang bastang
manisi ng nagdeliver or ng Contract
Giver.
III. THE CONTRACT
⚫ Should be drawn up between the
Contract Giver and the Contract
Acceptor which specifies their
respective responsibilities relating to
the manufacture and control of the
product.
Make sure na products are in good
condition all the time.
⚫ Technical aspects of the contract
should be drawn up by competent
persons suitably knowledgeable in
pharmaceutical technology, analysis
and Good Manufacturing Practice.
Well-trained dapat employees or
personnel to make sure na okay lahat
ng nasa product.
⚫ All arrangements for manufacture and
analysis must be in accordance with
the MA and agreed by both parties.
⚫ Should specify the way in which the
authorized person releasing the batch
for sale ensures that each batch has
been manufactured and checked for
compliance with the requirements of
Marketing Authorization.
⚫ Should describe clearly who is
responsible for purchasing materials,
testing and releasing materials,
undertaking production and quality
controls (in-process controls,
responsible for sampling and analysis.)
Dapat daw detailed talaga mga cotract
kaya nga daw sila mahaba. Mas okay
na daw yon para hindi ka mabutasan. It
should also be analyzed by a lawyer.
⚫ In the case of contract analysis, the
contract should state
whether or not the Contract Acceptor
should take samples at the premises of
the manufacturer.
Everything should be indicated there.
⚫ Manufacturing, analytical and
distribution records, and reference
samples should be kept by, or be
available to, the Contract Giver.
Parang nakastate na doon if ever
magkadefect, anong gagawin ng
contract acceptor. Iindicate na ng
Contract giver.
⚫ Any records relevant to assessing the
quality of a product in the event of
complaints or a suspected defect must
be accessible and specified in the
defect/recall procedures of the Contract
Giver.
⚫ The contract should permit the
Contract Giver to visit the facilities of
the Contract Acceptor.
⚫ In case of contract analysis, the
Contract Acceptor should understand
that he is subject to inspection by the
competent Authorities.
For example, si Ma’am daw supplier,
tapos acceptor nya is UniLab. Pwede
siya mag inspect, tignan if stored or
managed properly yung product. Para
di ma-scam pag sinabi nilang binigay
mo sa kanila na may defect.
Pag daw sinasabing erasures are
wrong tinuturuan lang daw nila tayong
maging mas vigilant.
Pag daw QC ka, tas may sinubmit ka
sa QA, ask them to sign something.
Kahit di naman contract, basta written
proof na nangyari yon. Dapat detailed,
lagay mo submitted by, received by,
ganon.
3 - PHARMACEUTICAL MANUFACTURING - CURRENT GOOD MANUFACTURING PRACTICES
COMPLAINTS AND PRODUCT RECALL
(SECTION VIII)
PRINCIPLE
✓ All complaints and other information
concerning potentially defective products
must be carefully reviewed according to
written procedures.
✓ A system should be designed to recall, if
necessary, promptly and effectively
products known or suspected to be
defective from the market.
COMPLAINTS
⚫ A person should be designated
responsible for handling the complaints
and deciding the measures to be taken
together with sufficient supporting staff
to assist him.
So nung nagttrabaho daw si Ma’am sa
TGP, may Aluminum Hydroxide tablet
na nireklamo. It is a Maalox counterpart.
Chewable daw kasi dapat siya tas
nireklamo kase ang tigas daw. Tinry
nguyain ni Ma’am tas di nya parin daw
kaya. Tinry nya daw idissolve sa tubig
tsaka vinegar pero wala parin daw
nangyari. Nagfile sya ng complaint.
Walang nangyari. May seminar daw sa
CEU tas nakita nya kung kanino nya
inaddress yung complaint. Sinubmit
naman daw nung head pero walang
nagreply hakhak.
⚫ There should be written procedures
describing the action to be taken,
including the need to consider a recall,
in the case of a complaint concerning a
possible product defect.
⚫ Any complaint concerning a product
defect should be recorded with all the
original details and thoroughly
investigated.
⚫ If a product defect is discovered or
suspected in a batch, consideration
should be given to checking other
batches in order to determine whether
they are also affected.
Do random checks parin sa other
batches para sure.
⚫ In particular, other batches which may
contain reworks of the defective batch
should be investigated.
The person responsible for Quality
Control should normally be involved in
the study of such problems.
⚫ All the decisions and measures taken
as a result of a complaint should be
recorded and referenced to the
corresponding batch records.
⚫ Complaints records should be reviewed
regularly for any indication of specific or
recurring problems requiring attention
and possibly the recall of marketed
products.
⚫ Special attention should be given to
establishing whether a complaint was
caused because of counterfeiting.
(basta di naapprove ng FDA cconsider
daw na counterfeit)
⚫ The Competent Authorities should be
informed if a manufacturer is
considering action following possibly
faulty manufacture, product
deterioration, detection of
counterfeiting or any other serious
quality problems with a product.
Alamin kung saan banda sa process
nagkaroon ng mali. May counterfeit ba
or may nagdeteriorate ba.
RECALLS
⚫ A person should be designated as
responsible for execution and
co-ordination of recalls and should be
supported by sufficient staff to handle
all the aspects of the recalls with the
appropriate degree of urgency.
⚫ This responsible person should
normally be independent of the sales
and marketing organization.
Binring up lang to ni ma’am ewan ko
anong connect nya sa nasa slide
masyado. Pero yung Rosiglitazone,
Brand name: Avandia, is an oral insulin,
for diabetes. Meron siyang adverse
effects sa heart, so nag wworsen ng
cardiovascular problems.
⚫ There should be established written
procedures, regularly checked and
updated when necessary, in order to
organize any recall activity.
⚫ Recall operations should be capable of
being initiated promptly and at any time.
May sufficient stocks dapat ng products
in case need mag withdraw
immediately.
3 - PHARMACEUTICAL MANUFACTURING - CURRENT GOOD MANUFACTURING PRACTICES
⚫ All Competent Authorities of all
countries to which products may have
been distributed should be informed
promptly if products are intended to be
recalled because they are, or are
suspected of, being defective.
Example:
Lumiracoxib, brand name Prexige,
was withdrawn nung 2007. COX-2
Inhibitor sya parang sina celecoxib and
etoricoxib.Wala pang 3 months pinull
out na daw sa market due to
cardiovascular side effects.
We are all guinea pigs daw talaga lalo
na sa COVID-19 vaccine. Pero sabi ni
maam wala pa daw narrecall na
vaccine due to physical and chemical
instability. So side effects lang talaga
inaalala ng iba, pero nagrelease
naman daw ng age bracket na pwede
para sa mga vaccines.
Yung narecall lang daw na COVID
19-related is yung testing kit ng UP NIH
na sa PGH lang ginamit.
⚫ The distribution records should be
readily available to the person(s)
responsible for recalls.
⚫ Record should contain sufficient
information on wholesalers and directly
supplied customers (with addresses,
phone and/or fax numbers inside and
outside working hours, batches and
amounts delivered), including those for
exported products and medical
samples.
⚫ Recalled products should be identified
and stored separately in a secure area
while awaiting a decision on their fate.
Tignan If pwede pang ayusin or may
remedy pa, baka may need ka lang
kasing iadd. Pero kung may kailangan
bawasan syempre mahirap yern.
⚫ The progress of the recall process
should be recorded and a final report
issued, including a reconciliation
between the delivered and recovered
quantities of the products.
Alamin kung gaano kadami yung
nadeliver, atsaka kung gaano kadami
yung narecover. This is your way of
knowing kung ilan yung narelease sa
public or yung naibenta na.
⚫ The effectiveness of the arrangements
for recalls should be evaluated
regularly.
SELF INSPECTION (SECTION IX)
PRINCIPLE
Self inspections should be conducted in order
to monitor the implementation and
compliance with Good Manufacturing
Practice principles and to propose necessary
corrective measures.
SELF INSPECTION
⚫ Should be examined at intervals
following a pre-arranged programme in
order to verify their conformity with the
principles of QA.
Eto lahat ng iniinspect sa
self-inspection or internal audit.
 Personnel matter
 Premises & equipment,
 Documentation
 Production & quality control,
 distribution of the medicinal products,
 Arrangements for dealing with
complaints and recalls,
 Self inspection
⚫ Should be conducted in an
independent and detailed way by
designated competent person(s) from
the company.
Naaassign dito yung mga tenured or
matagal na sa company.
⚫ Independent audits by external experts
may also be useful
Example sa AUF, we’re the ones who
ask PAASCU (external auditors) na
I-audit tayo para malaman kung quality
nga ba yung service na pinoprovide.
⚫ All self inspections should be recorded.
Internal auditors should record
everything, maganda man o hindi. You
should not sugar coat because this is
for the improvement of your products.
⚫ Reports should contain all the
observations made during the
inspections and, where applicable,
proposals for corrective measures.
⚫ Statements on the actions
subsequently taken should also be
recorded.
Report and Recording is very important
3 - PHARMACEUTICAL MANUFACTURING - CURRENT GOOD MANUFACTURING PRACTICES
sa manufacturing firm. This is more on
paper works.